Acetaminophen Diphenhydramine HCl
- Product NDC
- 68016-654
- 11-digit product format
- 680160654
- Labeler code
- 68016
- Product ID
- 68016-654_47f839b9-ac8b-161c-e054-00144ff8d46c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Diphenhydramine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chain Drug Consortium,LLC
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2016-02-25
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE
- Active strength
- 500; 25 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen Diphenhydramine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| DIPHENHYDRAMINE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 8GTS82S83M |
| Rxcui | 1092189 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-654-05 | Acetaminophen Diphenhydramine HCl | 50 in 1 BOTTLE | TABLET | 50 | | 1 |
| 68016-654-10 | Acetaminophen Diphenhydramine HCl | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-654 | ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [CHAIN DRUG CONSORTIUM,LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20170214_47f839b9-ac8a-161c-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68016-654-05 | 68016065405 | 50 TABLET in 1 BOTTLE (68016-654-05) | 50 tablet | 2016-02-25 | 0000-00-00 | No | No | Current |
| 68016-654-10 | 68016065410 | 100 TABLET in 1 BOTTLE (68016-654-10) | 100 tablet | 2016-02-25 | 0000-00-00 | No | No | Current |